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Impact of newer drugs and techniques on the quality of ambulatory anesthesia.

Recent pharmacologic and technologic advances in anesthesia and surgery allow outpatients with complex medical problems to undergo a wide variety of diagnostic and surgical procedures on an ambulatory basis. Increasingly, however, anesthesia practitioners, as well as pharmacy and therapeutic committees, are demanding proof that a new, more costly drug or medical device is superior to existing products in achieving its desired effect, is associated with fewer adverse effects, enhances efficiency, and reduces health care costs. The new field of pharmacoeconomics has emphasized the importance of cost-effectiveness analyses that consider both direct and indirect costs of newer drugs and therapeutic modalities. As new biomedical technology is introduced to facilitate the perioperative management of patients (e.g., computerized anesthesia information management systems), evidence that these systems enhance our ability to continue to provide high-quality, cost-effective health care will assume increasing importance. Limitations in health care resources necessitate a careful reevaluation of our clinical practices with respect to choice of drugs, supplies, equipment, and even discharge criteria. Ambulatory anesthesia and surgery will continue to increase because of the potential cost savings for patients undergoing elective operations on an outpatient basis. However, the challenge we face will be to continue to provide high-quality anesthesia care at a reduced cost. A careful examination of commonly accepted (but unproven) clinical practice patterns will be necessary to meet this challenge.

Ambulatory Surgical Procedures↗

Ethical issues related to research involving children.

With the advent of pediatric biomedical technology research in the past few decades, concern for the rights of children as research subjects is increasing. This article offers an orientation for pediatric nurses regarding the historical background of protection of children's rights, ethical principles, ethical issues of consent and risk versus benefit, and nursing implications relating to research involving children.

Child↗

Research: the prerequisite for innovative strategies and technologies.

The search for new strategies and technologies for the control of yaws, a genuine but much neglected tropical disease problem, has been largely unsuccessful. This disease, with conspicuous early symptoms and a late crippling pathology, attracted the attention of the first generation of tropical doctors. As soon as specific therapy became available in the early part of the 20th century, mass treatment campaigns were started. The availability and efficacy of penicillin led some to anticipate yaws eradication; this expectation was not met but rather induced a false sense of security. After varying intervals resurgences occurred in several endemic regions. It is important to analyze this failure so that mistakes and underestimated or overlooked factors can be identified. On the whole, the main difficulty has been a lack of interest in a presumably disappearing disease and a consequent failure to take advantage of the benefits offered by recent advances in basic biomedical technology. Solid clinical, epidemiologic, and sociocultural data in connection with mass treatment and control are still needed. Research of high quality, with continuous assessment in the field, is a prerequisite for innovative strategies and technologies.

Adolescent↗

Government regulations on cellular therapy and proposed approach related with these products by KFDA.

Advances in biomedical technology has enabled the research and use of novel therapies in cellular transplantation. A number of trials using chondrocyte and autologous skin products are underway and will soon become commercially available for clinical utilization. However, the Korea Food and Drug Administration currently lack systematic regulations for efficacy and safety evaluation of the emerging therapies. Specifically, dose related studies are uncontrolled and availability of clinical research centers is inadequate. Thus, patients are receiving therapy without guidelines for indication, dose, and adequate safety profiles. We propose criteria for cases in which these therapies can be used and advocate IRB determined quality assurance for future research.

Biomedical Research↗

Privatized biomedical research, public fears, and the hazards of government regulation: lessons from stem cell research.

This paper discusses the hazards of regulating controversial biomedical research in light of the emergence of powerful, multi-national biotechnology corporations. Prohibitions on the use of government funds can simply force controversial research into the private sphere, and unilateral or multilateral research bans can simply encourage multi-national companies to conduct research in countries that lack restrictive laws. Thus, a net effect of government regulation is that research migrates from the public to the private sphere. Because private research receives less oversight and external scrutiny than public research, it can threaten the welfare and rights of human subjects, scientific progress and openness, and the quality of the approval process for new biomedical technologies. In order to avoid the harmful effects of government regulation of biotechnology, society should promote meaningful discussion and dialogue among scientists, industry leaders, and the public before resorting to regulatory solutions. Legislative or executive initiatives should be applied with great discretion and care, and should be crafted in such a way that they protect public health and safety, promote scientific progress, and avoid the hazards of privatized research and polarized debates.

Biotechnology↗

Human cell models for genetic engineering.

Technological advances made in molecular biology and culture of human and other mammalian cells in vitro have increased the ability to introduce functional genes into a variety of cell types. Subgenomic components of both DNA and RNA viruses are used as the eukaryotic components of many recombinant DNA vector constructs which are used for transfection either by a variety of methods to facilitate DNA uptake or as virions. This paper reviews some of the factors involved in expression, persistence, and recombination of the introduced genes. Also considered are the use of DNA transfection models to study human cancer or other diseases, the current status of gene therapy, and the use of human cells to produce biologicals. The need to better develop well-characterized human cell culture models from multiple organ sites and various cell types is a recurrent theme for all of these applications, including the role that such cells will play in understanding the functions for genes which will be identified in the human genome cloning project. With continued study and a better understanding of pathophysiology at the cellular and molecular levels should come the logical next step of adding genetically engineered human cells to the repertoire of acceptable biomedical technologies.

Cells, Cultured↗

Dynamic, electronically switchable surfaces for membrane protein microarrays.

Microarray technology is a powerful tool that provides a high throughput of bioanalytical information within a single experiment. These miniaturized and parallelized binding assays are highly sensitive and have found widespread popularity especially during the genomic era. However, as drug diagnostics studies are often targeted at membrane proteins, the current arraying technologies are ill-equipped to handle the fragile nature of the protein molecules. In addition, to understand the complex structure and functions of proteins, different strategies to immobilize the probe molecules selectively onto a platform for protein microarray are required. We propose a novel approach to create a (membrane) protein microarray by using an indium tin oxide (ITO) microelectrode array with an electronic multiplexing capability. A polycationic, protein- and vesicle-resistant copolymer, poly(l-lysine)-grafted-poly(ethylene glycol) (PLL-g-PEG), is exposed to and adsorbed uniformly onto the microelectrode array, as a passivating adlayer. An electronic stimulation is then applied onto the individual ITO microelectrodes resulting in the localized release of the polymer thus revealing a bare ITO surface. Different polymer and biological moieties are specifically immobilized onto the activated ITO microelectrodes while the other regions remain protein-resistant as they are unaffected by the induced electrical potential. The desorption process of the PLL-g-PEG is observed to be highly selective, rapid, and reversible without compromising on the integrity and performance of the conductive ITO microelectrodes. As such, we have successfully created a stable and heterogeneous microarray of biomolecules by using selective electronic addressing on ITO microelectrodes. Both pharmaceutical diagnostics and biomedical technology are expected to benefit directly from this unique method.

Electrodes↗

Technology penetration of endovascular aortic aneurysm repair in southern California.

Our objective was to investigate the penetration of endovascular abdominal aortic aneurysm repair (EVAR) in the large, diverse health-care market of southern California over 3 years and to study variability in the pattern of distribution of EVAR in southern California counties by analyzing available demographic, geographic, and socioeconomic data from California state health-care databases. Information abstracted from the inpatient hospital discharge data for patients undergoing AAA repair for the years 2001, 2002, and 2003, derived from the Office of Statewide Health Planning and Development, included age, gender, race, hospitals performing EVAR, and payors for the service. Per-capita income (PCI) for the year 1999 and the population size of each county for the respective years were obtained from the U.S. Census Bureau. Data pertaining to members of the Southern California Vascular Surgical Society (SCVSS) serving the southern California region were obtained from the SCVSS membership directory. Data were categorized based on 10 counties in southern California. All the above variables were analyzed using the chi-squared test, with p < 0.05 considered significant. The proportions of EVAR for the years 2001, 2002, and 2003 were 15.4% (n = 409), 20.2% (n = 492), and 25.9% (n = 566), respectively. This is a 67.8% (p < 0.0001) increase in EVAR application in southern California since 2001. However, the proportion of EVAR varied among counties (p < 0.0001), with 457 EVARs performed in Los Angeles County and eight in Imperial County during the study period. EVAR proportion was higher in patients aged > or =65 years (p < 0.0001) and male patients (p < 0.0001). The proportion of EVAR was significantly higher in counties with more than 20 vascular surgeons available (p < 0.0001) and PCI >21,000 US$ (p < 0.0001) and in Medicare, health maintenance organization, preferred provider organization, and private insurance holders (p < 0.0001). There was a trend toward increased EVARs in counties with more than eight hospitals that performed EVAR (p = 0.0545). However, no significant difference in EVAR proportion was observed among subgroups based on race (p = 0.535) and population size (p = 0.84). Although the number and proportion of EVAR increased significantly in southern California over 3 years, the penetration of the procedure varied among counties. County affluence, payor mix, and the number of vascular surgeons/county influenced the variability. These observations suggest that economic barriers may limit access to new biomedical technology. This has implications for health-care public policy directed toward providing equal access to medical care without regard to economic status.

Age Distribution↗

Determination of blood flow velocity and transit time in cerebral arteriovenous malformation using microdroplet angiography.

Advancement in imaging and biomedical technology has improved the use of catheter-based transarterial embolization (occlusive therapy) of cerebral arteriovenous malformations (AVMs). Among a variety of embolic agents, liquid adhesives (acrylates) have proven to be more successful in permanent obliteration of AVMs. The use of liquid adhesives requires the experience and skill of the operator. However, acquiring accurate information on blood flow and transit times through the AVM prior to embolization can optimize the treatment. In addition, knowledge of the polymerization time and behavior of the acrylate enables a complete and safe occlusion of the arteriovenous transition within the AVM nidus. Standard commercially available iodine-based contrast agents seem to be insufficient to determine AVM transit times from angiograms. For a more accurate assessment of AVM transit times, the use of a nonsoluble contrast agent (Ethiodol) and a high-speed digital subtraction angiography (DSA) is suggested. Small amounts (<20 microl) of Ethiodol were infused to create microdroplets and traced using DSA at 15 fps. Transit time, defined as the time interval required for a droplet to reach the venous part of the AVM after being flushed from the tip of the catheter, could be accurately calculated. Postprocessing was used to calculate trajectories and velocities of microdroplets.

Angiography, Digital Subtraction↗

Use of direct posterior cricoarytenoid stimulation in laryngeal paralysis.

There are several methods used to restore impaired respiratory and phonatory function to the paralyzed larynx; but none are satisfactory. After we critically reviewed all available methods, we proposed a technique to rehabilitate the bilaterally paralyzed larynx, using selective stimulation of the posterior cricoarytenoid (PCA) muscle. This technique has the following advantages over existing methods: (1) preservation of phonation, (2) less chance of aspiration than with arytenoidectomy, and (3) reversibility. Adaptation of existing biomedical technology used in conjunction with any of several methods of triggering with respiration would make this a practical method. After insertion of electrodes into the PCA muscle of anesthetized animal subjects, selective electrical stimulation of this muscle was successfully accomplished. A significant reproducible increase in glottic area was demonstrated. Applicability to those suffering from bilateral laryngeal denervation seems feasible and functionally superior to existing methods of rehabilitation.

Animals↗

Delineation of clinical conditions: conceptual models of 'physical' and 'mental disorders.

The dysfunctional consequences of the Cartesian dichotomy have been enhanced by the power of biomedical technology. Technical virtuosity reifies the mechanical model and widens the gap between what patients seek and doctors provide. Patients suffer 'illnesses'; doctors diagnose and treat 'diseases'. Illnesses are experiences of discontinuities in states of being and perceived role performances. Diseases, in the scientific paradigm of modern medicine, are abnormalities in the function and/or structure of body organs and systems. Traditional healers also redefine illness as disease: because they share symbols and metaphors consonant with lay beliefs, their healing rituals are more responsive to the psychosocial context of illness. Psychiatric disorders offer an illuminating perspective on the basic medical dilemma. The paradigms for psychiatric practice include multiple and ostensibly contradictory models: organic, psychodynamic, behavioural and social. This mélange of concepts stems from the fact that the fundamental manifestations of psychosis are disordered behaviours. The psychotic patient remains a person; his self-concept and relationships with others are cental to the therapeutic encounter, whatever pharmacological adjuncts are employed. The same truths hold for all patients. The social matrix determines when and how the patient seeks what kind of help, his 'compliance' with the recommended regimen and, to a significant extent, the functional outcome. When physicians dismiss illness because ascertainable 'disease' is absent, they fail to meet their socially assigned responsibility. It is essential to reintegrate 'scientific' and 'social' concepts of disease and illness as a basis for a functional system of medical research and care.

Culture↗

Antibody-guided diagnosis: an Italian experience on CEA-expressing tumours.

Within the Italian CNR Biomedical Technology programmes a large multicentre clinical trial on CEA-expressing carcinomas has been carried out. F(ab')2 fragments of anti-CEA monoclonal antibody (MAb) FO23C5, radiolabelled with either 131I or 111In, were supplied to 10 different Italian nuclear medicine departments. Over 500 patients with gastrointestinal, lung, breast, and other carcinomas have been investigated. The results obtained in our nuclear medicine department are reported here. In GI cancer group, the 131I compound showed better results except in liver metastases detected only in 28/57 patients. In the lung cancer group, very satisfactory results were achieved in primary tumours and local or systemic recurrences: 111In tracer was preferentially used. In the breast cancer group immunoscintigraphy proved to be helpful in differential diagnosis of neoplastic and benign bone lesions. Significant improvements of diagnostic sensitivity were achieved in GI cancer patients by means of i.p. administration. Finally, 12 patients with advanced disease were given different 131I radioiodinated MAbs (100 mCi average dose). Administration route was either i.v. (3 cases) or i.p. (9 cases). Clinical and instrumental evidence of complete (1) or partial (7) response was observed in 8 patients.

Antibodies, Monoclonal↗

Structural effects of crosslinking a biopolymer hydrogel derived from marine mussel adhesive protein.

In an effort to explore new biocompatible substrates for biomedical technologies, we present a structural study on a crosslinked gelatinous protein extracted from marine mussels. Prior studies have shown the importance of iron in protein crosslinking and mussel adhesive formation. Here, the structure and properties of an extracted material were examined both before and after crosslinking with iron. The structures of these protein hydrogels were studied by SEM, SANS, and SAXS. Viscoelasticity was tested by rheological means. The starting gel was found to have a heterogeneous porous structure on a micrometer scale and, surprisingly, a regular structure on the micron to nanometer scale. However disorder, or "no periodic structure", was deduced from scattering on nanometer length scales at very high q. Crosslinking with iron condensed the structure on a micrometer level. On nanometer length scales at high q, small angle neutron scattering showed no significant differences between the samples, possibly due to strong heterogeneity. X-ray scattering also confirmed the absence of any defined periodic structure. Partial crosslinking transformed the viscoelastic starting gel into one with more rigid and elastic properties.

Animals↗

Measuring functional skills in preschool children at risk for neurodevelopmental disabilities.

Approximately 400,000 preschool children have a major neurodevelopmental disorder impacting on mobility, cognitive-adaptive, or communicative skills. As many as 1 in 3 children live at psychosocial disadvantage because of poverty, parental mental illness or substance misuse, or low parental educational (i.e. less than high school). In the past decade over 500,000 preschool children have survived being born with very low birth weight (1001-1500 g) or extremely low birth weight status (< or =1000 g). Given the scope of these risks and the importance of optimizing outcomes for vulnerable children, this review will highlight advances in functional assessment using adaptive and multiattribute health-related quality of life measures. A framework based on the International Classification of Functioning, (ICF) World Health Organization and the Dynamic Kaleidoscope Model of the Institute of Medicine (IOM) will be described and illustrated with examples of children receiving new biomedical technologies. Assessment scales were chosen for review if they measured adaptive skills or multiattribute health status and had been used in child disability populations. Instruments reviewed include the Infant and Toddler Quality of Life Questionnaire (ITQOL), The Netherlands Office of Prevention Assessment of Preschool Quality of Life (TAPQOL), the Health Status Classification System-PreSchool (HSCS-PS), the Pediatric Evaluation of Disability Inventory (PEDI), the Vineland Adaptive Behavior Scale (VABS), the Warner Inventory of Developmental and Emerging Adaptive and Functional Skills (Warner IDEA-FS), the Scales of Independent Behavior Revised (SIB-R) Early Development Form, the Pediatric Functional Independence Measure (WeeFIM), and the Pediatric Quality of Life Inventory Version 4 (PedsQL 4.0). By measuring functional and adaptive skills and health-related quality of life, we can help devise intervention strategies that optimize developmental independence, family supports, and community participation among children who are at risk for neurodevelopmental disabilities or who have evolving established neurodevelopmental disabilities.

Child, Preschool↗

Optimal Control of Directional False Discovery Rates in Large-Scale Testing.

The high-throughput biomedical technology enables measurement of thousands of gene expression levels contemporaneously. A major task in analyzing these gene expression data is to identify both over-expressed and under-expressed genes. The popular two-group models select the non-null genes without further classifying them as overexpression or underexpression. Consequently, two-group decision rules are unable to constrain the numbers of falsely discovered over-expressed or under-expressed genes respectively. We propose a general three-group model that allows dependence between the test statistics and develop a decision rule that separately controls the two types of false discoveries. We show that the optimal decision rule in our three-group model has a special monotonic structure. By making use of this monotonic structure, we can linearize the two-directional false discovery rate constraints. We prove that our decision rule optimizes the expected number of true discoveries while controlling the proportions of falsely discovered over-expressed and under-expressed genes at desired levels simultaneously. The data-driven versions of the proposed procedures are suggested, and their consistency is established. Comparisons with state-of-the-art approaches and applications to genomic studies show that our procedures work well.

Humans↗

Integrative and interactive studies of the cardiac system: deciphering the cardionome.

The cardiac system, denoted as the Cardionome, represents one of the most exciting challenges to human ingenuity. Critical to our survival, it consists of a tantalizing array of interacting phenomena, from ionic transport, membrane channels and receptors through cellular metabolism, energy production, fiber mechanics, microcirculation, and electrical activation to the clinically observed global functions. These are measured by pressure, volume, shape, coronary flow, heart rate, and other changes. It is a complex interactive system requiring the intense efforts of capable scientists in the life sciences, including medicine, exact sciences, engineering and biomedical technology devoted to address these multivariable, multidisciplinary challenges, so as understand and control the pathologies involved. Here we present some of our past interactive studies and highlight two new models, one demonstrating micro to macro integration, and one involving tissue-organ interaction of various parameters. These models yield new insights into cardiac performance.

Animals↗

Disease and illness. Distinctions between professional and popular ideas of sickness.

The dysfunctional consequences of the Cartesian dichotomy have been enhanced by the power of biomedical technology. Technical virtuosity reifies the mechanical model and widens the gap between what patients seek and doctors provide. Patients suffer "illnesses"; doctors diagnose and treat "diseases". Illnesses are experiences of discontinuities in states of being and perceived role performances. Diseases, in the scientific paradigm of modern medicine, are abnormalities in the function and/or structure of body organs and systems. Traditional healers also redefine illness as disease: because they share symbols and metaphors consonant with lay beliefs, their healing rituals are more responsive to the psychosocial context of illness. Psychiatric disorders offer an illuminating perspective on the basic medical dilemma. The paradigms for psychiatric practice include multiple and ostensibly contradictory models: organic, psychodynamic, behavioural and social. This mélange of concepts stems from the fact that the fundamental manifestations of psychosis are disordered behaviours. The psychotic patient remains a person; his self-concept and relationships with others are central to the therapeutic encounter, whatever pharmacological adjuncts are employed. The same truths hold for all patients. The social matrix determines when and how the patient seeks what kind of help, his "compliance" with the recommended regimen and, to a significant extent, the functional outcome. When physicians dismiss illness because ascertainable "disease" is absent, they fail to meet their socially assigned responsibility. It is essential to reintegrate "scientific" and "social" concepts of disease and illness as a basis for a functional system of medical research and care.

Attitude of Health Personnel↗

Intelligent systems in patient monitoring and therapy management. A survey of research projects.

Although today's advanced biomedical technology provides unsurpassed power in diagnosis, monitoring, and treatment, interpretation of vast streams of information generated by this technology often poses excessive demands on the cognitive skills of health-care personnel. In addition, storage, reduction, retrieval, processing, and presentation of information are significant challenges. These problems are most severe in critical care environments such as intensive care units (ICUs) and operating room (ORs) where many events are life-threatening and thus require immediate attention and the execution of definitive corrective actions. This article focuses on intelligent monitoring and control (IMC), or the use of artificial intelligence (AI) techniques to alleviate some of the common information management problems encountered in health-care environments. This article presents the findings of a survey of over 30 IMC projects. A major finding of the survey is that although significant advances have been made in introducing AI technology in critical care, successful examples of fielded systems are still few and far between. Widespread acceptance of these systems in critical care environments depends on a number of factors, including fruitful collaborations between clinicians and computer scientists, emphasis on evaluation studies, and easy access to clinical information.

Artifacts↗